Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects

This study has been terminated.
(Terminated new protocol developed which incorporated Pharmacokinetics)
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00765856
First received: October 2, 2008
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

Patients will convert from current opioid to Oxymorphone ER and undergo titration. During the Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s) every 12 hours. Dosing adjustments will be based on the review of the subject's pain scores. Oxymorphone IR 5 mg will be provided to be used as supplemental "breakthrough" pain medication (as needed). Titration Period will end when the fixed dose of study medication is tolerated and the subject achieves adequate analgesia. Subjects will then proceed to the open-label 3-month maintenance period on the fixed dose of study medication established during the Titration Period.


Condition Intervention Phase
Chronic Pain
Drug: Oxymorphone IR - Opioid
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • Change in pain intensity from baseline to last assessment using the FPS-R. [ Time Frame: From baseline up to 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assessment of AEs, vital signs, and physical examinations. [ Time Frame: Duration of the study ] [ Designated as safety issue: Yes ]

Enrollment: 27
Study Start Date: October 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Opana® ER
Oxymorphone IR - Opioid
Drug: Oxymorphone IR - Opioid
Opana IR 5mg tablet
Other Name: Opana®

Detailed Description:

An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have chronic cancer or non-cancer pain, currently requiring treatment of pain with a strong opioid for at least 5 days (3 of 5 days at a dose greater than or equal to 45 mg/daily (qd) oral morphine equivalent)
  • Weigh at least 50 kg
  • Expected to continue to require a strong opioid for pain relief for at least 4 weeks and up to 4 months.

Exclusion Criteria:

  • Have a life expectancy <4 weeks
  • Plan to undergo a surgical procedure within 3 days of study entry or during the Titration Period
  • Have dysphagia or difficulty swallowing whole tablets
  • Have a previous exposure to oxymorphone
  • Have an ileostomy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765856

Locations
United States, Arkansas
Arkansas Childrens's Hospital-Division of Pediatric Anestesia and Pain Medicine
Little Rock, Arkansas, United States, 72202
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Colorado
The Children's Hospital
Aurora, Colorado, United States, 80045
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
Florida Institute of Medical Research
Jacksonville, Florida, United States, 32257
Tukoi Clinical Research
Miami, Florida, United States, 34104
St. Joseph's Children's Hospital of Tampa
Tampa, Florida, United States, 33618
United States, Georgia
Taylor Research, LLC
Marietta, Georgia, United States, 30060
United States, Indiana
Rehabilitation Associates of Indiana
Indianapolis, Indiana, United States, 46250
United States, Kentucky
University of Louisville Reserach Foundation, Inc.
Louisville, Kentucky, United States, 40202
United States, North Carolina
The Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Hershey Medical Center
Hershey, Pennsylvania, United States, 17112
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Study Director: Sr. Director CR&D Endo Pharmaceuticals
  More Information

No publications provided

Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00765856     History of Changes
Other Study ID Numbers: EN3202 036
Study First Received: October 2, 2008
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:
Opioid tolerant
Pediatric
Male 6-17 years of age
Female 6-17 years of age
Pain
Non malignant
Malignant

Additional relevant MeSH terms:
Oxymorphone
Analgesics, Opioid
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on July 29, 2014